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Statistical Design and Analysis in Pharmaceutical Science: Validation, Process Controls, and Stability de Shein-Chung Chow

Statistical Design and Analysis in Pharmaceutical Science: Validation, Process Controls, and Stability

Autor Shein-Chung Chow, Jen-pei Liu
en Limba Engleză Paperback – 19 iun 2019
"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."
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Specificații

ISBN-13: 9780367401870
ISBN-10: 0367401878
Pagini: 580
Dimensiuni: 152 x 229 x 33 mm
Greutate: 0.45 kg
Ediția:1
Editura: CRC Press
Colecția CRC Press
Locul publicării:Boca Raton, United States

Public țintă

Professional Practice & Development

Cuprins

Assay development; assay validation; scaleup design and analysis; USP tests and specifications; process validation; quality assurance; stability studies; accelerated testing; design for long-term stability studies; stability analysis with fixed batches; stability analysis with random batches. Appendices: statistical tables; SAS programs; regulations. references.

Recenzii

". . .comprehensive. . ..a useful reference for practitioners as well as a good source for statisticians wishing to understand some of the key issues in these aspects of drug development. "
---Publication of the International Statistical Institute
". . .Particularly appealing in this book are the extensive explanations of technical concepts, beginning with a fine overview. . .and continuing as concepts such as assay validation, process validation, quality assurance, and stability studies are introduced subsequently. "
---Technometrics

Descriere

"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."